| Method for performing fed-batch operations in small volume reactors -> Monitor Keywords |
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Method for performing fed-batch operations in small volume reactorsRelated Patent Categories: Chemical Apparatus And Process Disinfecting, Deodorizing, Preserving, Or Sterilizing, Chemical Reactor, Bench ScaleMethod for performing fed-batch operations in small volume reactors description/claimsThe Patent Description & Claims data below is from USPTO Patent Application 20070178023, Method for performing fed-batch operations in small volume reactors. Brief Patent Description - Full Patent Description - Patent Application Claims
RELATED APPLICATIONS [0001] This application claims priority under 35 U.S.C. .sctn.119(e) to U.S. Provisional Patent Application No. 60/739,689, filed Nov. 23, 2005 by Russo et al., and entitled "Method for Performing Fed-Batch Operations in Small Volume Reactors". FIELD OF INVENTION [0002] The present invention relates to methods for forming chemical and/or biological products in reactors and/or analyzing chemical and/or biological interactions in reactors and, more specifically, to methods for forming chemical and/or biological products and/or analyzing chemical and/or biological interactions in small volume reactors. BACKGROUND [0003] Large scale reactions, including large scale bioreactions, are routinely used to produce a variety of end products including, for example, pharmaceutical agents, such as drugs. The reactions typically occur in large scale reactors that are used to contain the reactants and reaction media and to control environmental factors. Often, these reactions use live cells in a bioreactor to produce an end product. Processes in large scale reactors are typically designed to include a growth environment that yields maximum product. Thus, conditions need to be carefully controlled at specific points throughout the reaction. Variations in reaction conditions (parameters) in large scale reactors such as changes in temperature, pH, shear, nutrient levels, metabolite levels and oxygen concentration can have an affect on the efficiency and the outcome of the process. A slight change in one parameter can substantially alter the output of a large scale reaction. While systems are typically designed to control these parameters within a range, there is often enough variation in a system to reduce or alter yields, shorten cell lifetimes or even to upset the reaction process. [0004] In some instances, small scale reactors can be used to learn about reaction conditions and to develop information facilitating the design and/or tuning of large scale reactors. Scaling of small scale reactors to match the conditions of large scale reactors, however, is not trivial; a defined fed-batch operation may be sufficient in a large scale reactor but not in a small scale reactor. For instance, in some fed-batch processes using large scale reactors, cells are grown in a batch regime and the reactor is fed with a solution without the removal of culture fluid. As such, the large scale reactor may contain a low initial volume of fluid. In a small scale reactor, however, a low initial volume may result in shear levels that are detrimental to the health and/or productivity of the cells contained within the reactor. [0005] Methods that could enable parameters of small scale reactors to correlate with those in large scale reactors, and vice versa, would be beneficial. SUMMARY OF THE INVENTION [0006] Methods associated with forming chemical and/or biological products in reactors and/or analyzing chemical and/or biological interactions reactors are provided. [0007] In one embodiment of the invention, a method of forming a product in a reaction site and controlling fluid volume in the site is provided. The method comprises providing a reaction site having a reaction site volume of less than 2 mL and containing a first volume of fluid including a reactant, wherein the first volume is greater than 80%, but less than 95%, of the reaction site volume and forming a product from the reactant in the reaction site. The method also includes removing from the reaction site a portion of fluid, homogenous with respect to fluid remaining in the reaction site after removal, such that the concentration of the reactant in the portion removed is substantially equivalent to the concentration of the reactant in the fluid remaining in the reaction site after removal and introducing a second volume of fluid into the reaction site. The volume of fluid remaining in the reaction site, after removing the portion of fluid and introducing the second volume, may be within 10% of the first volume. [0008] In another embodiment of the invention, a method of forming a product in a reaction site and controlling fluid volume in the site is provided. The method comprises providing a reaction site having a reaction site volume of less than 2 mL and containing a first volume of fluid including a reactant, wherein the first volume is greater than 80%, but less than 95%, of the reaction site volume, and forming a product from the reactant in the reaction site. The method also includes introducing a second volume of fluid into the reaction site, and removing a portion of fluid from the reaction site such that the volume of fluid remaining in the reaction site, after removing the portion of fluid and introducing the second volume, is greater than 80% but less than 95% of the reaction site volume. [0009] In another embodiment of the invention, a method of forming a product in a reaction site and controlling fluid volume in the site is provided. The method comprises providing a reaction site having a reaction site volume and containing a first volume of fluid including a reactant and forming a product from the reactant in the reaction site. The method also includes removing from the reaction site a portion of fluid, homogenous with respect to fluid remaining in the reaction site after removal, such that the concentration of the reactant in the portion removed is substantially equivalent to the concentration of the reactant in the fluid remaining in the reaction site after removal, and introducing a second volume of fluid into the reaction site, wherein the second volume is substantially equivalent to the volume of the portion removed so as to maintain the first volume in the reaction site. [0010] In another embodiment of the invention, a method of forming a product in a reaction site and controlling fluid volume in the site is provided. The method comprises providing a reaction site having a reaction site volume of less than 2 mL and containing a first volume of fluid including a reactant, forming a product from the reactant in the reaction site, and removing a portion of fluid from the reaction site. The method also includes introducing a second volume of fluid into the reaction site, wherein the second volume is substantially equivalent to volume of the portion removed so as to maintain the first volume in the reaction site, and maintaining a substantially constant level of shear during the course of forming the product, wherein the substantially constant level of shear is non-zero. [0011] Other advantages and novel features of the present invention will become apparent from the following detailed description of various non-limiting embodiments of the invention when considered in conjunction with the accompanying figures. In cases where the present specification and a document incorporated by reference include conflicting and/or inconsistent disclosure, the present specification shall control. If two or more documents incorporated by reference include conflicting and/or inconsistent disclosure with respect to each other, then the document having the later effective date shall control. BRIEF DESCRIPTION OF THE DRAWINGS [0012] Non-limiting embodiments of the present invention will be described by way of example with reference to the accompanying figures, which are schematic and are not intended to be drawn to scale. In the figures, each identical or nearly identical component illustrated is typically represented by a single numeral. For purposes of clarity, not every component is labeled in every figure, nor is every component of each embodiment of the invention shown where illustration is not necessary to allow those of ordinary skill in the art to understand the invention. In the figures: [0013] FIG. 1 is a schematic drawing illustrating a standard fed-batch process used to form a product in a reactor, according to one embodiment of the invention; [0014] FIG. 2 is a schematic drawing illustrating a method of forming a product in a reactor according to another embodiment of the invention; [0015] FIG. 3 is a schematic drawing illustrating another method of forming a product in a reactor according to another embodiment of the invention; [0016] FIG. 4 is a schematic drawing illustrating a reactor, according to another embodiment of the invention; [0017] FIG. 5 is a graph showing a comparison between cell growth in a standard fed-batch process and a "substantially constant volume" process according to another embodiment of the invention; [0018] FIG. 6 is a graph showing a comparison between nutrient and metabolite levels at the end of the processes for the cultures shown in FIG. 5 according to another embodiment of the invention; and [0019] FIG. 7 is a graph showing a comparison between cell growth in a standard fed-batch process and a substantially constant volume process according to another embodiment of the invention. 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